New blood pressure medications recalled over cancer-causing impurity

Vivimed Life Sciences Pvt. Ltd. has joined the long list of manufacturers who have issued a recall notice for blood pressure medications.

Vivimed is recalling 19 lots of losartan potassium tablets of 25 mg, 50 mg and 100 mg because of the detection of an impurity — N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) — that is above the Food & Drug Administration’s interim acceptable exposure limit of 9.82 ppm. Based on the available information, the FDA wrote in its recall summary, the risk of developing cancer in a few patients following long-term use of the product containing high levels of the impurity NMBA cannot be ruled out.

These losartan lots are made by Vivimed at its plant in Alathur, Chennai, India, and distributed by Heritage Pharmaceuticals Inc. in East Brunswick, New Jersey.

Losartan belongs to a class of medicines used for treating high blood pressure called angiotensin II receptor blockers. Some generic versions of other ARBs, such as valsartan and irbesartan, have also been recalled.

The identifying National Drug Code numbers associated with the Heritage distributed product are: